CHALLENGE:

To rescue a CRO managed trial that was severely behind plan having only enrolled half of the patients it needed. The client sought a data-led approach to determine the best course of action.

SOLUTION:

Conducted a deep analysis using the Phesi Trial Accelerator™ platform driven by the world’s largest trial database.

  • No major protocol design defects were noted. 
  • Phesi scenario modeling showed the optimal number of trial sites to be 142. 
  • The CRO had already activated 200 sites resulting in inadequate support for sites with the biggest potential to enroll.  
  • Phesi predicted that 60 sites would contribute the majority of patients. 
  • By monitoring performance against pre-defined parameters and immediately closing sites that had failed to contribute anything for more than 150 days, the optimal number of sites was achieved.

THE DATA:

IMPACT:

As Phesi predicted, enrollment cycle time was reduced with the trial completed in 27 months resulting in a Gross Site Enrollment Rate of 0.12 pts/site/month.

The client’s procurement function reported that Phesi saved more than $5 million through its analysis, “what if” scenario modeling and a 25% reduction in sites.

 

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